MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. VELARIS MATTRESS; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 633026CA

Device Problem Deflation Problem (1149)

Patient Problem Pressure Sores (2326)

Event Date 04/17/2023

Event Type  Injury  

Event Description

The nurse reported that the patient's pressure injury stage iv worsened and doubled in size (from l: 3.92cm x w:1.95 cm to l:6.39cm x w: 9.11 cm).Allegedly, the tubing running from the pump into the mattress was pinched which led to low air flow.The pump did alarm informing staff of the issue.

Manufacturer Narrative

Follow-up report was submitted to add udi.

• Brand Name: VELARIS MATTRESS
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• MDR Report Key: 17008596
• MDR Text Key: 315998684
• Report Number: 1419652-2023-00035
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05059441149927
• UDI-Public: (01)05059441149927(11)220217
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 633026CA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/21/2023
• Distributor Facility Aware Date: 05/02/2023
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/21/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/26/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention